CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

NCT03641092 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-12-01

No results posted yet for this study

Summary

Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development.

There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes).

Conditions

  • Parent-Child Relations
  • Parenting
  • Child Development
  • Child Behavior

Interventions

BEHAVIORAL

CenteringParenting Intervention

The CenteringParenting(CP) intervention includes group well child care visits during the first 24 months of life. Participants receive a journal with child safety, health and development information. The groups are co-led by a practitioner and support staff member. This bundled intervention supports healthy parent-child interactions and early learning through education and experiential learning within the well-child visit.

BEHAVIORAL

Routine Well Child Care

The Comparison Clinical Sites will receive the Routine Well Child Care standard individual clinical care. This clinic will receive delayed training in the CenteringParenting(CP) intervention approximately 3 months after the completion of recruitment at their study site \[when recruited families will be ineligible for CenteringParenting groups that will start in control sites\]. They will receive anticipatory guidance and handouts that are standard for the clinic.

Sponsors & Collaborators

  • Centering Healthcare Institute

    collaborator OTHER
  • Overdeck Family foundation

    collaborator OTHER
  • Valhalla Foundation

    collaborator OTHER
  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Renee Boynton, MD, ScD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03641092 on ClinicalTrials.gov